The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0740-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Otezla 30 mg Tablets for Processing Control Issues

Kroger Specialty Pharmacy is recalling Otezla 30 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths. The hazard is a manufacturing process issue ('Lack of Processing Controls') without specific reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Otezla 30 mg tablets (NDC 59572-0631-06, 30-day supply) due to a lack of processing controls. The recall covers all lots remaining within their expiration date that were dispensed between December 1, 2017, and February 12, 2018.

The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The specific quantity of units recalled is not stated in the source text.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on what to do with the recalled product.

The recalled product

Product
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 67 recalled by Kroger Specialty Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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